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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028155
Receipt No. R000032225
Scientific Title The effectiveness of de-escalation to cefmetazole for bacteremia. Open-label randomized non-inferiority trial
Date of disclosure of the study information 2017/07/10
Last modified on 2017/07/10

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Basic information
Public title The effectiveness of de-escalation to cefmetazole for bacteremia. Open-label randomized non-inferiority trial
Acronym De-escalation to cefmetazole
Scientific Title The effectiveness of de-escalation to cefmetazole for bacteremia. Open-label randomized non-inferiority trial
Scientific Title:Acronym De-escalation to cefmetazole
Region
Japan

Condition
Condition bacteremia
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Cefmetazole, a cefamycin has activity against ESBL producing bacteria and preceding retrospective studies demonstrated its efficacy. It is a promising agent to spare carbapenems. However, there is no prospective studies to confirm its efficacy and safety. The current study examines the effectiveness of cefmetazole as an de-escalating agent for those with bacteremia diagnosed by blood cultures, comparing with those without de-escalation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Mortality at 30 days after entry.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 de-escalation to cefmetazole 1g every 6-8 hours for about 10-14 days, depending on renal function of the patients.
Interventions/Control_2 Continues current treatment for about 10-14 days, depending on renal function of the patients.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Bacteremic patients diagnosed by blood cultures, and those who were judged to be eligible for de-escalation to cefmetazole by infectious diseases doctors.
Key exclusion criteria When the patient or the physician treating did not consent to the study participation. Those who had or are likely to have significant past history of cefmetazole side effects, such as anaphylaxis by beta-lactams.
Target sample size 184

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Iwata
Organization Kobe University
Division name Division of Infectious Diseases
Zip code
Address Kusunokicho 7-5-2, Chuoku, Kobe
TEL 078-382-6297
Email kentaroiwata1969@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Toko Nakata
Organization Kobe University
Division name Division of Infectious Diseases
Zip code
Address Kusunokicho 7-5-2, Chuoku, Kobe
TEL 078-382-6297
Homepage URL
Email kobeid@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2017 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032225

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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